Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES found in Windstone custom surgical kits because the gloves may contain splits or holes that compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility is compromised, posing a risk of infection or harm to patients during surgery, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in custom AMS kits. The recall was initiated because the gloves may contain splits or holes that compromise sterility.
The affected gloves are part of Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D, and PSS2365(E convenience custom kits used for general surgery in hospital operating rooms. These kits were manufactured by Windstone Medical Packaging, Inc. and distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Hospitals and healthcare facilities should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the affected gloves are found, they should be removed from service and returned to the manufacturer or disposed of according to facility policy.
The recalled product
- Product
- Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 3,444
Distribution
Part of a larger recall action
This product is one of 150 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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